The FDA is “willing to review” an updated submission for Capricor’s Duchenne cell therapy, its CEO said. Elsewhere, a heart drug battle spilled into court and Rigel priced the first “Protac” medicine.
Capricor surged 60% after FDA agreed to review amended deramiocel (DMD therapy) with upper limb focus despite prior panel rejection. Regulatory opening demonstrates rare-disease biotech survival strategy: narrow efficacy claims to overcome rejection, extend review, and reset valuations.
An article from
News roundup
The FDA is “willing to review” an updated submission for Capricor’s Duchenne cell therapy, its CEO said. Elsewhere, a heart drug battle spilled into court and Rigel priced the first “Protac” medicine.
Published Aug. 14, 2026
Getty Images
US stocks: Capricor shares 77% soar as potential FDA lifeline revives Duchenne drug hopes
Why Is Capricor Therapeutics Stock Soaring Today? - Capricor Therapeutics (NASDAQ:CAPR)
Capricor, seeking lifeline for Duchenne therapy, says it will ask FDA to review additional data
Capricor Therapeutics Shares Surge 67.22% After Hours - Capricor Therapeutics (NASDAQ:CAPR)
Capricor Therapeutics shares surged significantly after the FDA agreed to review new drug data. The company had faced setbacks…
FDA briefing documents question Capricor's deramiocel efficacy in DMD, while the company defends its trial analysis ahead of July…
Capricor shares lost much of their value ahead of a high-stakes advisory committee meeting. Elsewhere, Ying Huang’s resignation…
FDA staff say Capricor's deramiocel fails to show clear efficacy for Duchenne, tanking shares 65%+ ahead of this week's adcomm…
Ahead of a hearing, the FDA raised questions about the benefits of a Duchenne treatment from Capricor Therapeutics, another twist…
Capricor Therapeutics highlights Deramiocel's FDA review, commercial readiness, and cash position of $approximately $237.9…
